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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K211395
Device Name NIO-I
Applicant
Einstein Works, LLC
5312 Elm St.
Houston,  TX  77081
Applicant Contact Roy Bachrach
Correspondent
Einstein Works, LLC
5312 Elm St.
Houston,  TX  77081
Correspondent Contact Roy Bachrach
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
MHC  
Date Received05/05/2021
Decision Date 07/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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